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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01899014
Other study ID # NL43466.068.13
Secondary ID 2013-000456-17
Status Active, not recruiting
Phase Phase 3
First received July 10, 2013
Last updated April 9, 2015
Start date July 2013
Est. completion date December 2015

Study information

Verified date April 2015
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a sensitive molecular tracer for PET-CT imaging that is taken up in activated cells and, as such, is able to identify active inflammatory sites.


Description:

Accumulation and subsequent activation of inflammatory cells in the atherosclerotic plaques play an essential role in transforming a stable plaque into a vulnerable plaque at risk to rupture. On this basis, the study aims to evaluate the diagnostic performance of 18F-choline PET-CT in identifying ongoing inflammation within atherosclerotic plaques. We hypothesize that 18F-choline is efficient in detecting intraplaque inflammation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is a female or male of ay race age >18 years at the time of the investigational product administration (no maximum age);

- Informed consent by signing informed consent form regarding this study;

- Patients known with carotid artery stenosis >50%, who are scheduled for carotid endarterectomy.

Exclusion Criteria:

- Dementia, pregnancy, nursing mothers;

- Patients who do have a documented allergy for CT contrast media;

- Patients with a renal clearance <45 ml/min/1.73m2 or <60 ml/min/1.73m2 in patients with diabetes mellitus;

- Serious neurological deficits at symptomatic side (hemi paralysis, complete aphasia);

- Severe heart failure NYHA III-IV and severe pulmonary dysfunction dependent on oxygen supply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
18F-choline PET-CT imaging
18F-choline PET-CT imaging

Locations

Country Name City State
Netherlands University Hospital Maastricht Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Center for Translational Molecular Medicine

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Bucerius J, Schmaljohann J, Böhm I, Palmedo H, Guhlke S, Tiemann K, Schild HH, Biersack HJ, Manka C. Feasibility of 18F-fluoromethylcholine PET/CT for imaging of vessel wall alterations in humans--first results. Eur J Nucl Med Mol Imaging. 2008 Apr;35(4):815-20. doi: 10.1007/s00259-007-0685-x. Epub 2008 Jan 6. — View Citation

Förster S, Rominger A, Saam T, Wolpers S, Nikolaou K, Cumming P, Reiser MF, Bartenstein P, Hacker M. 18F-fluoroethylcholine uptake in arterial vessel walls and cardiovascular risk factors: correlation in a PET-CT study. Nuklearmedizin. 2010;49(4):148-53. doi: 10.3413/nukmed-0299. Epub 2010 Jun 8. — View Citation

Kato K, Schober O, Ikeda M, Schäfers M, Ishigaki T, Kies P, Naganawa S, Stegger L. Evaluation and comparison of 11C-choline uptake and calcification in aortic and common carotid arterial walls with combined PET/CT. Eur J Nucl Med Mol Imaging. 2009 Oct;36(10):1622-8. doi: 10.1007/s00259-009-1152-7. Epub 2009 May 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To correlate the 18F-choline uptake in the atherosclerotic plaque with the degree of intraplaque inflammation, as assessed on histology. 1 year No
Secondary To correlate the intra-plaque 18F-choline uptake on PET with other histologic plaque parameters besides inflammation. 1 year No
Secondary To correlate the intra-plaque 18F-choline uptake on PET with atherosclerotic plaque parameters assessed on CT, MRI, and ultrasound. 1 year No
Secondary To compare on PET the 18F-choline uptake in the symptomatic carotid plaque with the uptake in the asymptomatic contralateral carotid artery. 1 year No
Secondary To evaluate a possible association between the degree of 18F-choline uptake on PET with patients' cardiovascular risk profile and medical history. 1 year No
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